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Open European Data Interchange and Processing for Computerised Electrocardiography

Objective

Early detection of life threatening changes in coronary heart diseased patients is probably one of the most challenging issues of the nineties. Detecting and analysing serial electrocardiographic (ECG) changes is up to now the only practical investigation which will assist the physician in early diagnosing acute myocardial infarction and in advising administration of thrombolytics and/or admission in a coronary care unit. This implies that a reference ECG and any relevant clinical information have already been stored, with the perspective of their future use, either on central databases, or on individual data cards, and that the data will be accessible even in emergency situations from home or during the transport in an ambulance.

The first objective of the OEDIPE project is thus to implement and experiment electronic data interchange of digital ECGs following the lines of the SCP-ECG standard communications protocol developed during the preliminary AIM phase, setting-up demonstrators for cart-to-host and host-to-host communications and exchanging ECG and other related data between several test sites.

Another objective is to implement and to test the Conceptual ECG data storage Reference Model which has been developed during the preliminary AIM phase and to set-up a European demonstration database for the follow-up of heart transplant patients. Operational testing will include the follow-up of patients suffering from acute myocardial infarction during their transportation in the emergency car or after their admission in a coronary care unit and the follow-up of patients during experimental drug studies.

The third objective is to develop and to test methods of serial ECG analysis for the early detection of acute myocardial infarction, the diagnosis of acute and chronic heart transplant rejection and the follow-up of patients suffering from chronic coronary disease.

The final objective is to promote open European data interchange and processing for Electrocardiography by setting-up demonstrator systems for the follow-up of selected heart diseased populations which will prefigure large-scale monitoring of ambulatory or critical ill patients at home, during their transportation in an emergency car or during their stay in a hospital.
A project has been designed to:
implement electronic data interchange electrocardiography (ECG) following the lines of the Standard Communications Pro Computerized Electrocardiography (SCP-ECG) standard communications protocol;
set demonstrators for cart to host and host to host communications;
exchange ECG and data between several test sites;
implement test the Conceptual ECG data storage which has been developed.

The project has successfully implemented the SCP-ECG communications protocol and the related compression algorithms on stand alone, i microprocessor based ECG carts from different makes and on personal computer bas acquisition systems. A new 32 multichannel ECG acquisition system has been desig the information content of the ECG recordings. Demonstrators for open cart to ho have been developed and tested. Demonstrators for host to host ECG data intercha developed.

With respect to the Conceptual ECG data Reference Model and the sett experimental European network of distributed cooperative ECG databases, a core m developed which complies with the data content of the SCP-ECG protocol.
The arch hardware and software which supports the functional requirements imposed by host interchange and serial ECG analysis were specified. Several system architectures considered, from bedside integration of the different data processing steps, up distributed data processing. To design an open and cooperative system, a client was adopted. The overall scene of quantitative electrocardiography was explored. potential use of quantitative electrocardiography, including serial ECG analysis methods for the follow up of heart transplant patients. A general review of the and Potential Benefits of Serial ECG Analysis has been produced.

Interfaces wit or serial ECG analysis programs and with ECG communication packages are being wr
Technical Approach

Setting-up demonstration systems for the follow-up of heart diseased persons is basically a problem of distributed, cooperative processing of patient signals and other relevant data, some of which are stored in distant distributed cooperative databases. Taking a systemic approach, we may consider such an ECG processing system as composed of three main components :
- an open network of distributed, heterogeneous cooperative data-bases,
- means for interchanging electrocar-diographic data,
- algorithms for comparing serial records and providing objective decision support.

The OEDIPE project will specifically address each of these components in three distinct, but highly interrelated workpackages. During the first year, the project has successfully implemented the SCP-ECG standard communications protocol and the related compression algorithms on stand-alone, industry standard microprocessor based ECG carts from different makes and on Personal Computer based ECG data acquisition systems (workpackage WP1). We have also designed a new 32 multichannel ECG acquisition system to increase the information content of the ECG recordings. Demonstrators for open cart-to-host data exchange have been developed and tested. Demonstrators for host-to-host electrocardiographic data interchange are being developed. Operational testing will include data transmission of multilead data for the follow-up of heart transplant patients and transmission from an emergency car to an emergency department via cellular phone.

The overall goal of workpackage WP2 is to implement and to test the SCP-ECG Conceptual ECG data Reference Model and to set-up an experimental European network of distributed cooperative ECG databases. The first step was thus to develop a core model which complies with the data content of the SCP-ECG protocol, and to solve some of the problems raised by its physical implementation which shall become effective in 1993. Another step towards the implementation of cooperative and distributed databases was to specify the architecture of the hardware and the software which shall support the functional requirements imposed by host-to-host data interchange and serial ECG analysis. Several system architectures have been considered, from bedside integration of the different data processing steps, up to networked distributed data processing. To design an open and cooperative system, we have adopted a client/server architecture. The databases may be queried by any client, SQL front-end and/or by any cart-to-host and host-to-host SCP-ECG demonstrators following the lines of the request functions defined by the SCP-ECG Standard Communications Protocol.

Digital ECG data will be stored at long-term with the perspective of its future use, particularly for serial comparison, but also for different managerial and research purposes. In Deliverable 1 we have explored the overall scene of quantitative electrocardiography and have focused on the potential use of quantitative electrocardiography, including serial ECG analysis, and on other methods for the follow-up of heart transplant patients. Deliverable 3 provides a general review of the "User Requirements and Potential Benefits of Serial ECG Analysis". Application area might include rest, stress testing and Holter ECG, and also the management of ECGs during pharmacological drug trials. Interfaces with existing unary or serial ECG analysis programs and with ECG communication packages are being written following the lines of SQL queries.

The ultimate goal of this project is to develop demonstration systems for the follow-up of cardiac diseased patients integrating serial analysis, decision support, open databases and communication protocols. The task of designing such serial cooperative ECG analysis systems in a distributed, heterogeneous client-server database environment will primarily be addressed by workpackage WP3. Problematics which need to be solved are :
- Management of the serial comparison process,
- Selection of a subset of relevant measurements (scalar, spatio-temporal, multilead ECGs, frequency spectra, ..),
- Graphical presentation of serial, patient dependent dynamic data (concept of personalised representation of data),
- Optimisation of lead sets for emergency cars or home recording,
- Assessment of performance of serial analysis methods,
- Optimisation of the decision process.

Key Issues

The main issues of the OEDIPE project will be :
- Demonstrators for open cart-to-host and host-to-host ECG data inter-change,
- An experimental European network of distributed cooperative ECG databases,
- An experimental European serial ECG database for the follow-up of heart transplant patients,
- A serial ECG analysis demonstration system for the follow-up of heart transplant patients and of coronary diseased patients,
- An efficiency analysis report on serial ECG measurements.

Relationships to Previous Work

This OEDIPE project is the continuation of the SCP-ECG (Standard Communications Protocol for Computerised Electrocardiography) project of the AIM preliminary phase and also of CSE (Common Standards for Quantitative Electrocardiography), a large international collaborative action performed under the aegis of the DGXII within the frame of successive Medical and Public Health Research Programmes. Having standardised computer derived ECG measurements, developed reference databases for quantitative electrocardiography, and set up minimum standards for testing the diagnostic performance of ECG computer programs, the three University partners which pilot the OEDIPE project have then succeeded in bringing together the leading experts and manufacturers in the field of computerised electrocardiography and have defined a universal communications protocol for the inter-change of electrocardiograms. Acting as a functional pre standard, the SCP-ECG universal communications protocol has then been worked out by Project Team CEN/TC251/PT007 and submitted to CEN-TC251 which approved the SCP protocol as an ENV in January 1993.

Expected Impact

Coronary artery disease is already the major cause of morbidity and mortality, with a very high socio-economic impact on each of the EC member states.
Electrocardiography, which is very widespread, is the only practical investigation method which allows early detection of coronary heart disease at a minimum cost. It is also the only reference method for detecting or predicting life threatening rhythm disturbances. Performing serial analysis further allows to overcome the limits of standard computerised electrocardiography, i.e. inter-subject variability, and thus may considerably improve the overall diagnostic accuracy of the whole interpretation process.
However, the lack of open communication and interlinking of various equipment and the difficulty to overcome the island solutions proposed by the manufacturers has hitherto been a significant problem. OEDIPE will open this field, implement the most recent serial diagnostic strategies, and demonstrate how integration of medical information systems and widening access to improved services may increase the efficacy of diagnosis and treatment of cardiac diseased patients.

Relationship to Other Projects and Actions

The OEDIPE project has found cooperation with the following AIM projects whose scope is complementary to OEDIPE :
- FEST : Framework for European Services in Telemedecine (A2011),
- SEISMED : Secure Environment of Information Systems in Medicine (A2033).

In addition, the OEDIPE project has relations with projects 25 from the CTS programme (Conformance Testing Services) and with the CEN TC251 working group 5.

Testbed Sites and Verification

Methods applied in the DGXIII Conformance Testing Services (CTS) Programme (Project 25) will be applied to test the quality of the transmission and compression of the digital ECG. Portability of software and interconnectability of databases will be tested. The stability of the serial analysis measurement results will be assessed in a normal control group and in a group of cardiac patients. Operational testing will also include data collection and transmission of multi-lead data for the follow-up of heart transplant patients and transmission from emergency cars to emergency departments via cellular phone for cases with acute myocardial infarction which need early treatment with thrombolytic agents.

Coordinator

Institut National de la Santé et de la Recherche Médicale (INSERM)
Address
28 Avenue Du Doyen Lepine
69500 Lyon-bron
France

Participants (4)

Bull Europe
France
Address
68 Route De Versailles
78430 Louveciennes
Elettronica Trentina SpA
Italy
Address
Via De Zinis 6
38011 Cavereno Trento
K.U.L. UNIV. HOSPITAL GASTHUISBERG
Belgium
Address
49 Herestraat
3000 Leuven
MEDIZINISCHE HOCHSCHULE HANNOVER
Germany
Address
Konstanty-gutschow Straße 8
3000 Hannover